Just Because It’s Generic Doesn’t Ensure It’s Safe

On his May 12th show, Dr. Oz recommended to his viewers that they always use a generic drug because, in general, such a drug has been given to a great many patients and more is known about its safety than a newer prescription medication. Ironically, Dr. Oz opened this same show talking about recent safety concerns that have arisen over the use of Alli. The active ingredient in Alli is orlistat, a drug discovered by Roche and sold under the trade name Xenical. The patent on orlistat has expired, so technically it is a generic drug. Clearly, Dr. Oz’s suggestion that generic drugs are safer is an oversimplification. His contradiction highlights the fact that the public needs to be better informed about what a generic drug is.

When a drug company invents a new medicine and has it approved by the FDA, it has a patent on the new medicine that allows this company an exclusive period of time (generally 10 – 12 years) during which it is the only company that can sell the drug. Once the patent for this medicine expires, it “goes generic” – that is, anyone can get approval from the FDA to make and sell this drug. In fact, the vast majority of prescriptions written every year are for generic drugs.

But just because a drug reaches generic status doesn’t automatically make it universally safe. It just means that its patent has expired and it can be made by a lot of other companies. Because it has been on the market for a number of years, more is understood about the risk-benefit profile of the medication at this point than when it was first marketed. However, the safety profile of the compound doesn’t change. As a generic, it still has the same side-effects it had when it was a branded drug. A great example of this is acetaminophen, the active ingredient in Tylenol. There is no difference between Tylenol, the branded drug, and acetaminophen sold under the name of the pharmacy you might use such as CVS. Acetaminophen has been taken by hundreds of millions of people around the world over the last 50 years. You can buy it in any drug store and most supermarkets. More is known about it than most prescription medications. And yet acetaminophen is the leading cause of calls to Poison Control Centers every year (>100,000). Acetaminophen accounts for more than 56,000 emergency room visits, 2,600 hospitalizations and an estimated 458 deaths annually as a result of acute liver failure. These incidents are largely due to overdoses of this drug, both intentional and unintentional.

So, the bottom line is that every medicine can cause a safety problem in people. It is impossible for a drug to be universally safe in males and females, old and young, people of different ethnic backgrounds, etc. People should only turn to medicines as a last resort. Lifestyle changes, diet and exercise are the sorts of things people should do before turning to pills. And when people do need to turn to medicines to alleviate their illness, they should discuss with their doctor the potential side-effects that the prescribed medication has. Yet, despite all of these caveats, medicines save lives, prevent serious debilitating diseases and improve the lives of millions of people each year.

2 Responses

I think his point was that by the time a drug reaches generic status, we know that much more about who should and shouldn’t be prescribed it. Take the anti-inflammatory Rofecoxib (Vioxx) for example. It was removed in 2004 due to the danger it posed to certain people. It was on the market for 5 years but was removed abruptly due to the danger it posed to patients with certain conditions. If they didn’t die, but rather experienced enough risky symptoms such as heart palpitations, it likely would have stayed on the market and would no longer be prescribed to people with a medical history of heart disease, high cholesterol, high Bp or who were obese. In other words, doctors’ prescriptions for a drug get safer over time due to the higher number of patient outcomes and side-effects they can learn from. Because a generic drug has been prescribed that many more times than a newer, different, currently-patented drug meant to treat the same condition, it is inherently safer due to its test of time.

Alex,
What I continually try to teach is that long usage doesn’t ensure safety. At the FDA Advisory Committee meetings that were held after Vioxx was withdrawn it was learned that generic drugs used for pain relief, commonly called NSAIDs, also elevated the risk that one had for heart attacks and strokes. As a result, the FDA had the labels revised for all pain relievers. The only way to get a good feel for the safety of a drug, generic or otherwise, is via a long-term outcomes study. But generic drug makers don’t have the resources to do these.
– John